In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
Voluntary participation and written informed consent must be signed.
Age between 18 and 70 years, male or non-pregnant female.
Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml.
Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
Patients who have previously received radiotherapy or systemic chemotherapy.
Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.